Randomized controlled trial: The gold standard or an unobtainable fallacy?

Abstract

Background: This article is the result of a debate at the European Journal of Orthodontics Open Session in 2013 in Reykjavik, Iceland. Objective: The aim of this article is to highlight some of the strengths and weakness of clinical orthodontic research, with particular emphasis on randomized controlled trials (RCT). The ultimate aim of improving clinical orthodontic research in general. Design: This article is organized into two sections with arguments for and against RCTs. The backgrounds to evidence-based evaluation and the level or quality of evidence in trials are discussed. The article emphasises what makes high quality clinical research, and gives practical advice including examples of tips and potential pitfalls for those undertaking clinical research. Results and Conclusion: The overriding message is constructive and it is hoped that the article serves as an aid in evaluating, designing, conducting, and reporting clinical research.